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| Name | Class |
|---|---|
| Eyefree Assisting Communication Ltd | INDUSTRY |
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The purpose of this study is to evaluate the feasibility of use of a wearable communication device for critically ill patients who are admitted to the intensive care unit (ICU) and mechanically ventilated. The study will assess the safety, tolerability, and ease of use of the EyeControl device, and examine its potential monitoring capabilities.
Critically ill patients, who are mechanically ventilated, suffer not only from their acute, potentially devastating illness, but also from the lack of ability to communicate in an effective manner. This is the direct result of the orotracheal tube or tracheostomy required for the mechanical ventilation, which does not allow speech to be produced. On top of the mechanical change in air flow, communication challenges result from sedation, neurological injuries (primary brain injury or secondary encephalopathy), and delirium.
Lack of communication can lead to increased frustration, anxiety, and overall psychological stress and could continue to the development of post-traumatic stress disorder (PTSD). On top of the subjective discomfort, the inability to communicate in an effective manner may impair medical care-for example, by failure to assess symptoms such as pain or breathing discomfort by behavioral cues only.
Currently, the solutions for communication deficits in mechanically ventilated patients are mainly using yes/no communication, attempting to write, and communication boards that allow people to point at defined pictures or letters. Recently, technological advancements led to incorporation of more sophisticated communication devices, proving the feasibility of an eye-tracking approach, for example.
The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. This approach eliminates the need for calibration, as most eye-tracking devices that use a screen require, and is relatively easy to operate.
This study will assess the safety, tolerability, and ease of use of the EyeControl device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EyeControl Eye-tracking Device | Experimental | Ventilated ICU patients using the EyeControl wearable, eye-tracking device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EyeControl Eye-tracking Device | Device | The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. Once the patient is able to operate the device, it will stay on the patient for as long as she or he would like it on, or until the patient is successfully extubated or discharged from the ICU, whichever is earliest. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Succeeded in Operating the EyeControl Device | Successful operation of the device was defined as completing a set of assignments termed as a proficiency test. This proficiency test included the ability to call for help and the ability to choose a correct answer out of multiple choice questions that were read to the patient using the device. Participants were able to try to learn to operate the device once per day for up to three days. | Up to Day 3 |
| Time To Successful Operation of the EyeControl Device | Successful operation of the device was defined as completing a set of assignments termed as a proficiency test. This proficiency test included the ability to call for help and the ability to choose a correct answer out of multiple choice questions that were read to the patient using the device. Participants were able to try to learn to operate the device once per day for up to three days. The time (in minutes) of training required for a patient to successfully operate the device was documented. | Up to Day 3 |
| Number of Participants Successfully Operating the EyeControl Device Per Attempt Day | Successful operation of the device was defined as completing a set of assignments termed as a proficiency test. This proficiency test included the ability to call for help and the ability to choose a correct answer out of multiple choice questions that were read to the patient using the device. Participants were able to try to learn to operate the device once per day for up to three days. The study day when participants passed the proficiency test was documented. | Up to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Days of Use | The duration of EyeControl device use and participation in the trial was recorded in days (participation in the trial ended when use of the device ended). Participants left the trial due to inability to operate the device, patient request, technical issues, and no longer needing the device (extubation, ICU discharge). | Up to end of study participation (up to 3 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ofer Sadan, MD, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40946530 | Result | Sadan O, Ratcliff JJ, Samuels OB, Hall AJ. A pilot study to assess the safety and feasibility of a wearable communication device in mechanically ventilated critically ill patients. J Crit Care. 2026 Feb;91:155259. doi: 10.1016/j.jcrc.2025.155259. Epub 2025 Sep 13. |
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Individual participant data that underlie results reported in the study publications (text, tables, figures, and appendices) will be available for sharing with other researchers, after deidentification.
Individual participant data will be available for sharing beginning one year after article publication, with no end date.
Non-study investigators and researchers (i.e., external) may submit their proposal to the study investigators for approval of methodologically appropriate proposals and inquiry. Data will be available for sharing in order to achieve aims in the approved proposal. Proposals should be submitted to the PI at ofer.sadan@emory.edu. Requestors will be required to execute a data use/transfer agreement to receive a limited dataset. Data will be provided directly to external investigators.
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Participants were recruited from Emory University Hospital in Atlanta, Georgia, USA. Participant enrollment began May 19, 2021 and all study assessments were completed by January 23, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | EyeControl Eye-tracking Device | Ventilated ICU patients using the EyeControl wearable, eye-tracking device. The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. Once the patient is able to operate the device, it will stay on the patient for as long as she or he would like it on, or until the patient is successfully extubated or discharged from the ICU, whichever is earliest. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | EyeControl Eye-tracking Device | Ventilated ICU patients using the EyeControl wearable, eye-tracking device. The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. Once the patient is able to operate the device, it will stay on the patient for as long as she or he would like it on, or until the patient is successfully extubated or discharged from the ICU, whichever is earliest. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Succeeded in Operating the EyeControl Device | Successful operation of the device was defined as completing a set of assignments termed as a proficiency test. This proficiency test included the ability to call for help and the ability to choose a correct answer out of multiple choice questions that were read to the patient using the device. Participants were able to try to learn to operate the device once per day for up to three days. | Posted | Count of Participants | Participants | Up to Day 3 |
|
Information on adverse events was collected beginning at the time patients gave consent to participate and continued up to extubation, ICU discharge, or when the participant wanted to stop using the device (up to 3 days).
Adverse events that were potentially related to study activities were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EyeControl Eye-tracking Device | Ventilated ICU patients using the EyeControl wearable, eye-tracking device. The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. Once the patient is able to operate the device, it will stay on the patient for as long as she or he would like it on, or until the patient is successfully extubated or discharged from the ICU, whichever is earliest. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient redness of the skin where device touches the skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ofer Sadan, MD, PhD | Emory University | 470-480-6956 | ofer.sadan@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2021 | Jan 19, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D003142 | Communication |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| ICU Type | Count of Participants | Participants |
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| Sequential Organ Failure Assessment (SOFA) Score at Admission | The SOFA score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). Each organ system is scored on a 5-point scale where normal = 0 and high degree of disfunction = 4. The total score ranges from 0 to 24 and a higher score indicating greater severity. A score of 0-6 is associated with a mortality rate of less than 10% while a score between 16 and 24 is associated with a greater than 90% mortality rate. | Median | Full Range | score on a scale |
|
| Body Mass Index (BMI) | Body mass index (BMI) is calculated as weight in kilograms (kg) divided by the square of the body height measured in meters (m). A BMI between 18.5 and 24.9 is considered to be normal weight. A BMI of 25-29.9 indicates overweight, while a BMI of 30 or more indicates obesity. | Mean | Standard Deviation | kg/m^2 |
|
| Experienced delirium during admission | Count of Participants | Participants |
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| Primary | Time To Successful Operation of the EyeControl Device | Successful operation of the device was defined as completing a set of assignments termed as a proficiency test. This proficiency test included the ability to call for help and the ability to choose a correct answer out of multiple choice questions that were read to the patient using the device. Participants were able to try to learn to operate the device once per day for up to three days. The time (in minutes) of training required for a patient to successfully operate the device was documented. | The population in this analysis includes the 11 participants who were able to successfully operate the device. | Posted | Mean | Standard Deviation | minutes | Up to Day 3 |
|
|
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| Primary | Number of Participants Successfully Operating the EyeControl Device Per Attempt Day | Successful operation of the device was defined as completing a set of assignments termed as a proficiency test. This proficiency test included the ability to call for help and the ability to choose a correct answer out of multiple choice questions that were read to the patient using the device. Participants were able to try to learn to operate the device once per day for up to three days. The study day when participants passed the proficiency test was documented. | The population in this analysis includes the 11 participants who were able to successfully operate the device. | Posted | Count of Participants | Participants | Up to Day 3 |
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|
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| Secondary | Days of Use | The duration of EyeControl device use and participation in the trial was recorded in days (participation in the trial ended when use of the device ended). Participants left the trial due to inability to operate the device, patient request, technical issues, and no longer needing the device (extubation, ICU discharge). | Posted | Median | Full Range | days | Up to end of study participation (up to 3 days) |
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| Post-Hoc | Clinical Characteristics of Participants Who Passed or Did Not Pass The Proficiency Test | Participants were stratified based on whether or not they passed the proficiency test and were able to successfully operate the EyeControl device. Clinical characteristics (tracheostomy, delirium, and exposure to certain medications) of these groups of participants were examined. | Posted | Count of Participants | Participants | Up to Day 3 |
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| Post-Hoc | SOFA Score of Participants Who Passed or Did Not Pass The Proficiency Test | Participants were stratified based on whether or not they passed the proficiency test and were able to successfully operate the EyeControl device. The Sequential Organ Failure Assessment (SOFA) Score at admission of these groups of participants was compared. The SOFA score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). Each organ system is scored on a 5-point scale where normal = 0 and high degree of disfunction = 4. The total score ranges from 0 to 24 and a higher score indicating greater severity. A score of 0-6 is associated with a mortality rate of less than 10% while a score between 16 and 24 is associated with a greater than 90% mortality rate. | Posted | Median | Full Range | score on a scale | Up to Day 3 |
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| Post-Hoc | Age of Participants Who Passed or Did Not Pass The Proficiency Test | Participants were stratified based on whether or not they passed the proficiency test and were able to successfully operate the EyeControl device. The mean age at admission of these groups of participants was compared. | Posted | Mean | Standard Deviation | years | Up to Day 3 |
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| 0 |
| 30 |
| 0 |
| 30 |
| 1 |
| 30 |
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| Exposure to fentanyl on day of attempt to use device |
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| Exposure to any benzodiazepine on day of attempt to use device |
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| Exposure to dexmedetomidine on day of attempt to use device |
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| Exposure to propofol on day of attempt to use device |
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| Exposure to any pressors on day of attempt to use device |
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